This invention relates to a system for detecting the moment of micturition in babies.
More particularly, this invention relates to a system which will interdict enuresis alarm circuitry incorporated in it or attached to it from being tricked into switching itself on when in fact the sensor striping, screens, clips or stripes used in and with swaddles or latest embodiment the plastic layered disposable diaper is not wet with urine but condensation permeated.
An inspection of the numerous art precursive to this invention amply demonstrates that enuresis monitors continue to present a challenge to practitioners in the art.
Although in the past, discoveries have resulted from a need to cater to the more obvious and embarrassed group that comprises higher age groups, our investigations have uncovered a critical area not previously challenged by others. Namely that a properly conceived micturition detector, when conceptualized standing alone or configured as an integrally featured structure of a disposable diaper, could possess the ability to alert a mother or other person to prognose agonal motor activity that is commonly associated with 85% of "Sudden Infant Death Syndrome" related deaths.
Because a CNS agonal episode of motor activity triggers a voiding of a baby's bladder, a prompt reaction with proper management of known resuscitation techniques will invariably result in a reduction of deaths caused by asphyxia or increased intrathoracic pressure resulting from involuntary neonatal laryngospasm, a condition that in babies has been diagnosed to be not unrelated to the common spasmodic "hiccough" generally well tolerated in higher age groups.
Whereas the authoritative Merck Manual, fourteenth edition, published by Merck Sharp & Dohme Research Laboratories, indicates that annually some 10,000 infant deaths reflect a "SIDS" (i.e., crib death) related classification, any help that breaks new ground in the art and can contribute to promoting fewer deaths, will obviously be beneficial to the public. By analogy, whereas 1 in every 350 live births in the United States of America terminates as a fatality to "SIDS," that statistic constitutes an unacceptable ratio by any measure, and it is to the improvement of that statistic that the novelty of this invention is addressed.
Although it is acknowledged that most voidings are generally not agonal episode related, a cautious attitude is nevertheless properly indicated, in particular, where for some medical reason or other reason, the parent(s) is precluded from conceiving a further offspring.
In the past, numerous systems have been conceived which purported to be micturition event monitors, but most suffered to one degree or other from an unacceptable susceptability to switching "ON" in response to mediums other than urine.
Notwithstanding in diversity remarkable and without doubt creative, the teachings of the prior art, taken broadly, have either not become commercially reproducible or have not seen their commercial production because of a failure to perform in real life as true micturition event monitors.
While it is true that the majority of the prior art has characterized itself as micturition event monitors, the assumed characterization has been found to possess little more than a grain of truth owing to the prior art having unfortunately misplaced its reliance on an erroneous proposition concerning the means to economically capture, identify and staff off the associated electronics from switching itself "ON" when micturition had not taken place.
Putting the case to point, the prior conceptions have failed to recognize the novelty that the effluent of urine offers a specific and measurable advantage over equally present and sharing mediums that generalized comprise perspiration condensation, related crotch surface lubricants, and higher up, involuntary nocturnal saliva escapes, and accordingly, urine's identification not being an easily palpable medium by heretofore arrangements or constituents of cloth or wire, no matter how ingeniously crafted. To their credit, some are indeed creditably more confortable than others in modern day applications where disposable diapers constitute the normal attire of babies whether berthed in the crib or on the go with today's traveling moms, but that is not the primary issue that we are speaking to.
It is in this misconceived concept that each prior patentee(s) alleges his or her invention an improvement over the referenced antecedent art, and has accordingly offered forth ever more unwieldly or commercially difficult to duplicate constructions for their "sensing" extensions or related peripherals to try and help overcome the propensity of associate alarm circuitries from being fooled into switching "ON" at the onset of perspiration condensation in the crotch area--instead of waiting and holding off switching said associated alarm circuitries "ON," until the event of actual micturition had factually manifested itself.
Quite obviously, none of the prior art has conceived the palpability of micturition manifestation by means of a sweep frequency oscillator terminating in a predesignated ratio demodulation system as indicated by the technique shown in this invention.
Whereas some early art characterized by U.S. Pat. Nos. 2,812,757; 3,696,357 and 4,163,449 downplay the tragic interference and "masking effect" that perspiration condensation problems in diapers cause systems when trying to acquisition the manifestation of micturition, by providing "sensitivity" potentiometers, as if thereby could obviate the preemptory interference caused by perspiration condensation imitating partial enuresis. Regal U.S. Pat. No. 4,163,449 in particular appears oblivious to its intrinsic limitations to a successful employment in neonatal management, by the obvious necessity that a baby would have to sleep naked and without the sanitary benefit of a diaper. This is so on account of the very nature of a baby's usually wearing of a diaper, and diapers, by reason of incorporated "elastic gathers," entrapping any effluent of urine from seepage into and soiling of the baby crib's sheeting, thereby consequently rendering any Regal or a likewise sensor bedpad device such as the Shuman U.S. Pat. No. 3,778,570, to be not only ineffective and superfluous, but to also be incompatible with ancillary baby care products as envisioned by the Friesen U.S. Pat. No. 4,438,771, entitled "Passive Contactless Monitor For Detecting Cessation of Cardiopulmonary Activity." Our invention on the other hand, can be used with any presently envisionable ancillary baby care products without concern on the part of parent or medical practitioner; and further, does provide numerous accessories for adaptation to its employment in unusual circumstances such as would be desirable with elderly users of disposable briefs because of loss of bladder control, available among others under the brand names of "Depends" or "Attends," as manufactured by the company of Procter & Gamble; and further still, will invariably hold off triggering any range of conceivable alarm circuitries, including unobtrusive pocketable tremblers, in the absence of a true micturition manifestation.
Other early art characterized by U.S. Pat. Nos. 2,127,538; 2,687,721; 3,245,068; 3,460,123; 3,971,371; 4,106,001 and 4,212,295 have skipped altogether and taught naught that might have shed light on the difficulty of suppressing premature perspiration-caused switching "ON" of the signal control apparatus, because the conceivers of the art simply had not conceptualized or could offer to the consumer a viable alternative to a knotty problem, which consequently left it up to the consumer to deal with the occurrence of false alarms in each own's fashion. Where we have been able to observe a definite limitation with the Regal patent, we are likewise disposed to identify that the Shuman patent similarly require that a baby lay naked in order for the Shuman device to function as prescribed, and it is for that reason, and the relational fact that all linen and blanketing would thereby find their repeated contamination conferred an undesirable coloration, that an objectionable appearance of uncleanliness has limited the desirability to lay babies naked on these manner of sensor bedpads, whatever may have been their means of construction, whether assembled by sandwiching absorbent pads and metal screens, or manufactured by laminating from multiple supply reels, or by stitching with metalized thread, a plurality of thin current conductive sensor strips to a predominant side of a presized thin bedpad of supportive substrate.
Taking a different approach, Baisden U.S. Pat. No. 3,508,235 sought to leverage a galvanic principal comprising dissimilar metals (i.e., zinc-silver) to generate a voltage in the presence of urine, but again failure was inevitable because, by test, fluids other than urine measured confusingly comparable EMF, using a JOHN FLUKE model 8200A D.V.M.
The majority of subsequent art characterized by U.S. Pat. Nos. 3,530,855; 3,696,357; 3,818,468 and 4,191,950, broke new ground by employing a free-running multivibrator conceived to output a fixed frequency upon the conductivity of urine simulating the closing of an electrical switch. But once again that art refused to fulfill its promise to hold off from switching "ON" except in the event of actual micturition, and finds its subsequent abandonment as preferred in U.S. Pat. No. 4,191,950, where based upon United Kingdom Pat. No. 1,174,346, Levin U.S. Pat. No. 4,191,950, interposes a variation on a Schmitt trigger between the "sensor" and a fixed frequency outputting into a speaker.
Reviewing the more recent art visible in U.S. Pat. Nos. 4,191,950; 4,484,573 and 4,539,559, and purchasing their marketed embodiments, we found the inventors denying the claimed exclusiveness of conception--by confessing in related instruction manuals, namely. "While the baby urinated or sweated much, its moisture will drive the switch of the baby bell." And indeed, multiple units procured to exclude defective samples have confirmed that all of them invariably preemptively triggered "ON" upon coming into contact with nothing more than oral saliva.
Studying the most recent proponents of the art, embodied by U.S. Pat. Nos. 4,356,818; 4,484,573; 4,539,559; 4,653,491 and 4,688,027, we find that the Okada U.S. Pat. No. 4,653,491, is a progeny of our earlier Macias U.S. Pat. No. 4,356,818, in particular with respect to our unique longitudinally extended metal layer being covered with a layer of electrical insulating material (i.e., FIGS. 3a, Nos. 130 and 131; in FIG. 3b, Nos. 13 and 26; and FIG. 13, Nos. 130 and 131. (all in the Macias patent)). Although essentially a tracing from our earlier patent, it should be noted that here again reliability is not guaranteed by the terms of the Okada patent (column 3, lines 1-7) in that had Okada included the features depicted in the Macias's patent as shown in FIGS. 8, 9, 10 and 11, Okada need not have had to warn against variations arising in the distance separating his metal layers, and thus need not have had to caution against capacitance uncertainties which arise when Okada's metal layers get crushed in the crotch of the wearer. Furthermore, Okada makes clear that his conception relates to a quantitative measurement of perspirated condensation (i.e., water) by the change it engenders in capacitance, proportional to area, rather than a qualitative measurement of urine manifestation.
As regards the Widener U.S. Pat. No. 4,688,027, we can appreciate the merits of his wipeable isolated molded sensor strip, although we cannot lose sight of the fact that in the Widener construction, placement of the strip appears to be critical in that only side of its "flats" is receptive to interrogating an adjacent surface--because only one side of the flats 12 is provided with a pair of groovings 38 and 40, filled with conductive material 14 and 16. It appears to us that the better arrangement would have been to have had the obverse "flat" (i.e., back-to-back) be similarly arranged, but we also recognize that Widener might have elected not to similarly accomodate the obverse side of the "flats" because of encountered difficulties with cracking or indeed breaking off of lengths of the strip due to fatigue of the sensor strip assembly, thereby resulting in a premature shortening of the strip and rendering useless the most expensive part of the strip, namely, the molded yoke assembly 18 comprising discrete resistors 30 and 32, and molded in place shielded cable 22 and plug 24. As will be further noted, the extreme emphasis Widener places on the use of shielded wire, by necessity infers that environmentally induced spikes or charges (i.e., by refrigerators, vacuum cleaners, etc.) will cause the proposed circuitry into unnecessarily triggering a false moist condition. Additionally, Widener has not acknowledged that there exists a 50/50 chance that the strip will not function when "For the primary application of sensing urine, sensor strip 12 is placed in the bedding within an absorbant pad between the sensor strip 12 and the patient." (column 4, lines 66-68), this because many a person will inadvertantly place the active "flat" of the strip face down, and thus pointed away from the source of urination; or the end of the strip opposite to the yoke's opening as claimed by Widener to be functional as a securing location for affixation by clip (column 3, lines 62-65), may even curl away or be involuntarily displaced to one side when the patient turns or moves in the restless tussle of sleep. Furthermore, it seems that Widener has left the erroneous impression that Shuman taught fabricating a urine-sensing pad on a roll which may be cut (supposedly by the consumer) to any desired length (column 1, lines 13-16). In fact a close reading of Shuman clearly discloses in column 1, lines 50-57, that a number of additional manufacturing steps are required before the product of the Shuman invention would have been ready for sale to the consumer, with Shuman's retail sales accordingly projected to have been on a pre-sized bedpad to bedpad basis.
From a clinical perspective, none of the prior art has been entirely successful whether the art having spawned as the result of a reduction to practice inconsistent with comfortable wearing as conceived in U.S. Pat. No. 3,441,019, or more recently as a result of efforts to narrow or lower the acceptance range in which toggelling by the signal control means genuinely causes a fixed audio frequency signal generator means to activate, immaterial whether the input to the signal control means be referenced to the high rail as shown in U.S. Pat. Nos. 3,441,019 and 4,191,950, or predisposed by trickle resistor as taught in U.S. Pat. No. 4,539,559.
From a different perspective, we have become well acquainted with cessation of respiration monitors, especially by Hewlett-Packard, because back in the 1960's, when we were conducting studies on parasitic interactions with other connected devices then typically in use in hospitals' neo-natal care suites, it is quite true, although not stated in Friesen U.S. Pat. No. 4,438,771, but referenced in Hochstein U.S. Pat. No. 4,279,257, that at that time, the most prominent of these devices, especially from the perspective of those available to the general public apart from the more specialized surgical suite instruments, that the instrument of choice was one that constituted slipping a retracting expansion belt about the chest of the patient, the umbilical cord of which was appropriately attached to a monitoring device placed on a table next to the patient's bed. Other devices not generally thought of as aspiration cessation monitors, but nevertheless could have been initially specifically so intended if had been intentionally so configured from their inception, are available in known and several variations on the theme presently known in the art as electronic snore depressors, a well known example for the study of this art and derivatives finding a good foundation in Crossley U.S. Pat. No. 3,480,010.
Although we respect the achievements made by Hochstein and Friesen, regretfully, neither the Friesen nor the Hochstein device will achieve their assumed popularity, because their employment will not prevent irreversible brain death, or severe tissue damage that will result (a) in permanent disability as a consequence of resuscitation applied too late, and, (b) as a result place the unfortunate parent(s) in a financial, emotional and spiritual struggle that is of enormous complication, this in essence because of oxygen deprivation of brain tissue cells that will have occurred before reflexive cardio-pulmonary relaxation will have permanently set in and connected alarms, designed to registering said relaxation as proposed by Friesen or Hochstein having sounded off.
A parential's close monitoring, on the other hand, of baby's micturitional displays, especially during the afternoon napping period when the majority of SIDS attacks take place (i.e., a REM related Hallucinatory neural activity not having been determined dispositive of contributory excitation) makes its own positive statement, in particular given the fact that an agonal motor activity attack will in likeness to an idiopathic (e.g., birth trauma) epileptic seizure, result in fecal and urinary incontinence. Because of the short time span between agonal motor activity onset and a micturition display, a shortened reaction time is afforded by the use of our invention over the Friesen or Hochstein devices which by their inherent teachings will have patiently continued to average out the reflexive costal regional convolutions preceeding cardio-pulmonary collapse until long after our invention will have sounded off, and in accordance with this prompt attention afforded by our invention over the Friesen or Hochstein inventions that react too late in the agonal cycle, the baby under properly caring observation need never face the prospect of being subjected to suffering from such prolonged oxygen deprivation that sadly erodes the practicability that went into the creativety underlying the Friesen or Hochstein inventions.
In recent years, high performance electrochemical detection has become commonplace, with salinity and conductivity meters available to anyone. Although the laboratory or industrial setting suits the available means, nothing is available to mothers in the scope of a device no larger than a couple of "half-a-dollar coins" stacked flat one on top of the other.
Regardless of the modes employed, be it by amperometric detection or across wheatstone bridges, heretofore available means have failed to conceptualize the novelty of "task specific toggelling," and all suffer from undue encumberances which include the need for a minimum off-set and temp-drift in the front end interface, a costly and blown proposition for the intended application; a manipulatable bias adjustment screw with its size and need for precision; an indicating device such as a meter or "magic eye" to show when the base line has been appropriately adjusted when null determining the bias potentiometer (10-turn); and last but not least in the case of electrochemical detectors, three (3) connecting leads feeding into the potentiostate out of conductivity cells generally made of glass or plastic material (configurated as gel-filled bulbs or double junction wands), or in the case of probes usual with salinity and conductivity meters, precious metal plated electrodes rigidly constrained in a strict relationship in probe housings and by their very inherent requirements, utterly unsuitable to monitor in the area of interest by baby.